The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan.
The Effect of Dupilumab on Intractable Chronic Rhinosinusitis with Nasal Polyps in Japan.
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DOI：
10.1002/lary.29230
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发表时间：
2021-06
期刊：
影响因子：
--
通讯作者：
Mannent L
中科院分区：
文献类型：
--
作者：
Fujieda S;Matsune S;Takeno S;Asako M;Takeuchi M;Fujita H;Takahashi Y;Amin N;Deniz Y;Rowe P;Mannent L
Dupilumab阻断白细胞介素-4和白细胞介素-13的共同受体组分，减少息肉大小、鼻窦混浊和症状严重程度，并且在SINUS-52研究（NCT 02898454）中慢性鼻窦炎伴鼻息肉（CRSwNP）患者中耐受良好。我们在日本研究中心入组的患者中评估了dupilumab。接受糠酸莫米松鼻喷雾剂背景治疗的患者接受dupilumab 300 mg每2周一次（q2 w）治疗，持续52周（A组）; dupilumab 300 mg q2 w治疗，持续24周，随后每4周一次（q4 w）治疗，持续28周（B组）;或安慰剂（C组）。共同主要终点为第24周鼻息肉评分（NLP）、鼻充血（NC）评分和鼻窦Lund-Mackay CT（LMK‐CT）评分。在52周治疗期间评估了症状、嗅觉、健康相关生活质量和安全性。在日本入组的49例患者中，45例完成了研究。第24周与安慰剂相比的最小二乘（LS）平均改善如下：（A组：-3.1，P < .0001; B组：-2.1，P = .0011）; NC评分（A组：-1.2，P < .0001; B组：-0.9，P < .0001）; LMK-CT（A组：-5.1，P = .0005; B组：-2.8，P = .0425）。dupilumab和安慰剂治疗患者中最常见的治疗后出现的不良事件为鼻咽炎。Dupilumab为日本CRSwNP患者提供了快速、显著和具有临床意义的改善。Dupilumab耐受性良好，安全性和疗效与总体研究人群一致。2喉镜，131：E1770-E1777，2021
Dupilumab, which blocks the shared receptor component for interleukin‐4 and interleukin‐13, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS‐52 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers. Patients on a background of mometasone furoate nasal spray, received dupilumab 300 mg every 2 weeks (q2w) for 52 weeks (Arm A); dupilumab 300 mg q2w for 24 weeks, followed by every 4 weeks (q4w) for 28 weeks (Arm B); or placebo (Arm C). Co‐primary endpoints were week 24 nasal polyp score (NPS), nasal congestion (NC) score, and sinus Lund–Mackay CT (LMK‐CT) scores. Symptoms, sense of smell, health‐related quality of life, and safety were assessed during the 52‐week treatment period. Of 49 patients enrolled in Japan, 45 completed the study. Week 24 least squares (LS) mean improvement versus placebo were as follows: NPS (Arm A: −3.1, P < .0001; Arm B: −2.1, P = .0011); NC score (Arm A: −1.2, P < .0001; Arm B: −0.9, P < .0001); and LMK‐CT (Arm A: −5.1, P = .0005; Arm B: −2.8, P = .0425). The most common treatment‐emergent adverse event in dupilumab and placebo‐treated patients was nasopharyngitis. Dupilumab provided rapid, significant, and clinically meaningful improvements for patients with CRSwNP in Japan. Dupilumab was well tolerated, and safety and efficacy were consistent with the overall study population. 2 Laryngoscope, 131:E1770–E1777, 2021
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影响因子：
12.4
作者：
Tokunaga T;Sakashita M;Haruna T;Asaka D;Takeno S;Ikeda H;Nakayama T;Seki N;Ito S;Murata J;Sakuma Y;Yoshida N;Terada T;Morikura I;Sakaida H;Kondo K;Teraguchi K;Okano M;Otori N;Yoshikawa M;Hirakawa K;Haruna S;Himi T;Ikeda K;Ishitoya J;Iino Y;Kawata R;Kawauchi H;Kobayashi M;Yamasoba T;Miwa T;Urashima M;Tamari M;Noguchi E;Ninomiya T;Imoto Y;Morikawa T;Tomita K;Takabayashi T;Fujieda S
通讯作者：
Fujieda S
影响因子：
2.6
作者：
Veloso-Teles, Rafaela;Cerejeira, Rui
通讯作者：
Cerejeira, Rui
影响因子：
1.4
作者：
Chung, Jae Ho;Lee, Yun Jae;Cho, Seok Hyun
通讯作者：
Cho, Seok Hyun
影响因子：
5.9
作者：
Peters, Anju T.;Spector, Sheldon;Slavin, Raymond G.
通讯作者：
Slavin, Raymond G.
DOI：
10.1016/j.jaip.2016.12.027
发表时间：
2017-07
期刊：
The journal of allergy and clinical immunology. In practice
影响因子：
--
作者：
Stevens WW;Peters AT;Hirsch AG;Nordberg CM;Schwartz BS;Mercer DG;Mahdavinia M;Grammer LC;Hulse KE;Kern RC;Avila P;Schleimer RP
通讯作者：
Schleimer RP